PulseSelect Based Pulmonary Vein Isolation and Ablation in Patients With Atrial Fibrillation

NCT07035288 | Completed

• 1 other identifier: 4895-18/03/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Electroanatomical mapping (EAM) based pulmonary vein isolation (PVI) by means of PulseSelect catheter and deep sedation will be compared to fluoroscopy based pulmonary vein isolation in patients with atrial fibrillation in the acute and long term (2 months remapping).

Conditions

Atrial Fibrillation (AF); Catheter Ablation; Pulmonary Vein Isolation

Keywords

Atrial Fibrillation (AF); Pulsed Field Ablation (PFA); Catheter Ablation; Electroanatomical Mapping; Pulmonary Vein Isolation (PVI); Fluoroscopy

Outcome Measures

Primary Outcomes (4)

• Durability of PVI

  Durability of pulmonary vein isolation based on a remap procedure after a follow up of at least 2 months post index procedure (percentage of patients with all PVs isolated, percentage of PVs isolated)

  2 to 3 months post index ablation

• PVI durability by means of a fluoroscopy-based or an EAM-based index procedure

  Comparison of PVI durability according to fluoroscopy-based or EAM-based index procedure Number of participants with treatment-related adverse events as assessed by CTCAE v4.0"

  2 to 3 months post index ablation

• Identification of pulmonary vein isolation gaps acutely based on EAM

  Mapping will be performed in all cases post PVI (either fluoroscopy-based or EAM-based)

  2 to 3 months post index ablation

• Identification of pulmonary vein isolation gaps on remap

  Remapping will be performed 2+ months post-index procedure

  2 to 3 months post index ablation

Secondary Outcomes (6)

• Fluoroscopy time and dose

  During index procedure

• First pass pulmonary vein isolation

  Index procedure

• Durability of superior vena cava isolation

  2-3 months post index procedure

• Procedure time

  During index procedure

• Left atrial access time to sheath removal

  During index procedure

Other Outcomes (1)

• Patient Safety

  2-3 months

Study Arms (2)

Fluoroscopy-based catheter ablation by means of PulseSelect catheter (Device)

ACTIVE COMPARATOR

In 20 patients, a fluoroscopy-based approach will be used for visualization of the PulseSelect catheter.

Device: Fluoro based pulmonary vein ablation

EAM-based catheter ablation by means of PulseSelect catheter (Device)

ACTIVE COMPARATOR

In 20 patients Carto 3 Prime® 3D-EAM system (Biosense Webster, Diamond Bar CA) system will be used for visualization of the PulseSelect catheter. Initially, a multipolar catheter (PentaRay®) will be used to map the left atrium pre-ablation.

Device: EAM based Pulmonary Vein Isolation

Interventions

EAM based Pulmonary Vein Isolation DEVICE

20 patients with symptomatic paroxysmal or persistent AF will be scheduled for pulmonary vein isolation (PVI) based to EAM by means of the PulseSelect catheter. Ablation will be performed in a deep sedation setting and additional ablation within the pulmonary veins will be assessed

Also known as: Catheter Ablation

EAM-based catheter ablation by means of PulseSelect catheter (Device)

Fluoro based pulmonary vein ablation DEVICE

20 patients with symptomatic paroxysmal or persistent AF will be scheduled for pulmonary vein isolation (PVI) based to Fluoroscopy by means of the PulseSelect catheter. Ablation will be performed in a deep sedation setting and additional ablation within the pulmonary veins will be assessed

Fluoroscopy-based catheter ablation by means of PulseSelect catheter (Device)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ALL the following criteria must be fulfilled:
• Male or female patients aged ≥18 and \<80 years old.
• Patients with paroxysmal or persistent AF requiring PVI.
• Signed written informed consent by the patient for participation in the study and agreement to comply with the procedure and the follow-up schedule

You may not qualify if:

• Patients with previous AF ablations
• EF\<35%, CABG surgery within previous 3 months, TIA or stroke within previous 6 months
• Patients were excluded if ineligible for treatment with oral anticoagulation.

Sponsors & Collaborators

• Tsiachris Dimitrios: lead
• Medtronic Atrial Fibrillation Solutions: collaborator

Study Sites (1)

First Department of Cardiology, National and Kapodistrian University of Athens, Hippokration General Hospital

Athens, Attica, 11527, Greece

Location

Related Publications (2)

• Kordalis A, Tsiachris D, Antoniou CK, Doundoulakis I, Tsioufis K. Verification of persistent pulmonary vein isolation with electroanatomical mapping 3 months after ablation using a novel PFA platform. Hellenic J Cardiol. 2024 Nov 19:S1109-9666(24)00232-X. doi: 10.1016/j.hjc.2024.11.002. Online ahead of print. No abstract available.

  PMID: 39566605 RESULT

• Tsiachris D, Antoniou CK, Doundoulakis I, Kordalis A, Stefanadis C, Tsioufis K. Single-center initial experience with a new pulsed-field ablation system: pulmonary vein isolation lesions and beyond. Future Cardiol. 2024;20(14):739-746. doi: 10.1080/14796678.2024.2413829. Epub 2024 Nov 19.

  PMID: 39560013 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Cardiology

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 25, 2025
• Study Start: November 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: July 10, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

GR (1)